Solvent/detergent-treated plasma: a tale of 30 years of experience

Abstract

Solvent/detergent-treated plasma was licensed >30 years ago. It has several specific characteristics, the most important being the standardized content of clotting factors, the lack of antibodies implicated in transfusion-related acute lung injury pathogenesis and the very high level of safety against transfusion-related viral infections. Since 1992, many clinical studies have confirmed its safety and efficacy in a wide range of congenital and acquired bleeding disorders. After a brief analysis of the pharmaceutical characteristics of solvent/detergent plasma, this review will focus on the clinical experience with this virus-inactivated plasma.

Keywords:

• clinical efficacy
• fresh frozen plasma
• solvent/detergent plasma
• transfusion-related acute lung injury
• virus inactivation

Financial & competing interests disclosure

The authors have no relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript. This includes employment, consultancies, honoraria, stock ownership or options, expert testimony, grants or patents received or pending, or royalties.

No writing assistance was utilized in the production of this manuscript.

Key issues

• Solvent/detergent (S/D) treatment for pathogen reduction of plasma for transfusion and plasma-derived medicinal products is the most common, validated and robust industrial method for the virucidal treatment of blood products.

• Preclinical virus validation studies, clinical safety virological assessments, and extensive post-marketing clinical experience have clearly shown that S/D treatment achieves a rapid, irreversible, and thorough inactivation of enveloped viruses.

• Very recently, a prion-depleted version of S/D plasma was introduced in the market.

• S/D industrial treatment of plasma provides a high level of safety toward allergic reactions and transfusion-related acute lung injury as well as a highly standardized content of coagulation factors.

• The reported differences of concentration of some clotting factor and inhibitor activities in S/D plasma are not clinically significant.

• Health technology assessments should include in the projected benefits of S/D plasma use the elimination/reduction of transfusion-related acute lung injury and (severe) allergic reactions as well as the prevention of transfusion transmitted emerging/unknown infectious diseases.